Botox Approved in the UK for Prevention of Chronic Migraine
Migraine prevention is a major concern for many of us, and we're always looking for more options. One option that more and more Migraineurs are investigating is Botox, botulinum toxin Type A.
For several years now, researchers in several countries have been conducting clinical trials to investigate the effectiveness of Botox injections in the prevention of Migraines and headaches. Friday, it was announced that Botox has been licensed by the MHRA in the UK for the prevention of Migraine in adults who have chronic Migraine. In this case, chronic Migraine was defined as headaches on at least 15 days per month of which at least 8 days are Migraine. This is the first license worldwide of Botox(R) for this indication, and is also the first prophylactic (preventative) treatment to receive a specific license for patients with chronic Migraine.
Scott Whitcup, M.D., Allergan's Executive Vice President, Research and Development and Chief Scientific Officer, stated:
"There is an unmet need for effective and well-tolerated therapies specifically designed and studied for the prophylaxis of headache in chronic Migraine. The authorisation of Botox(R) marks an evolution in medical care for the prevention of headache in adults with chronic Migraine. It is also a significant milestone in the history of Botox(R) and Allergan is proud to advance novel treatments in the field of neurology through our neurosciences research programme."2
This approval was based largely on the results of the PREEMPT (Phase III Research Evaluating Migraine Prophylaxis Therapy) clinical trial. PREEMPT is the largest clinical trial in chronic Migraine and consists of two phase III clinical trials involving 1,384 adults. Patients were eligible for the study if they had a history of Migraine and experienced 15 or more headache days of which at least 50% were Migraine or probable Migraine during the 28 day baseline period. In a pooled assessment, two thirds of the patients had previously been treated with at least one other headache prophylactic medication and nearly two thirds of the patients were overusing acute medications. During the 28-day baseline period, patients reported suffering from an average of 19.9 headache days (headache for four or more hours in any calendar day), of which an average of 19.1 were Migraine/probable Migraine days (Migraine headache on four or more hours in any calendar day).
At the end of the 28-day baseline period, patients were randomized to receive either 155 - 195 units of Botox(R) administered as 31 injections (155 units) into seven specific head and neck muscle with an additional up to eight injections (up to 40 units) into three of these muscles that could be administered in a 'follow the pain' strategy, or placebo. Patients received two injection cycles in a 24-week double-blind phase and then three injection cycles in a 32 week open label phase.
Throughout the PREEMPT trials, including the open label phase, patients received up to 5 courses of treatment with Botox(R) every 12 weeks. Most adverse events reported in the trials were mild to moderate and resolved without further problems. The treatment was generally well tolerated and the discontinuation rate was low in both treatment arms; 3.8% in the Botox(R) treated arm and 1.2% in the placebo arm4.
Dr. Peter Goadsby commented:
"This is an important step forward in the management of chronic Migraine and will hopefully bring additional recognition to this potentially disabling condition. Botox(R) treatment has been shown to reduce the frequency of headache/Migraine, which can bring important benefits for patients. Patients with frequent, chronic Migraine, have long required evidence-based approaches and this announcement offers them a new option, providing a real advance for patients often significantly impacted by their condition."
Lee Tomkins, Director of Migraine Action, stressed that BOtox is not a "cure," but it offers hope for those who suffer frequent Migraines, and commented:
"We have been following these studies really closely and the evidence is really pretty solid. These people spend half their lives in pain. Even if they get half the attacks, it can really improve their quality of life."1
Wendy Thomas, Chief Executive of The Migraine Trust, said patients who may be suffering from chronic Migraine should seek medical advice from neurologists or headache specialists to ensure proper diagnosis and care and:
"Chronic Migraine is currently an under-researched, under-diagnosed and under-treated condition. We know that treatment with acute pain medication does not always work for these patients so we welcome new therapies, especially preventative medication, for this potentially disabling condition." 2
Summary and comments:
This is good news, especially for Migraineurs in the UK. Hopefully, the FDA will approve Botox for the treatment of Migraine in the United States soon. Clinical trials are still underway in the U.S. If you're interested in participating in a clinical trial, you can find a listing of trials that are currently recruiting participants in our listing of Current Migraine and Headache Clinical Trials.
Dr. John Claude Krusz (Ask the Clinician) has been investigating Botox. You can read about some of his work with it in Intradermal Botox for Migraine, Headache, Pain Disorders.
1 "Botox approved for the prevention of chronic Migraine." BBC News. July 9, 2010.
2 Press Release. "Botox(R) Receives First Authorisation in UK as Preventative Treatment in Chronic Migraines."Allergan. Marlow, United Kingdom. July 9, 2010.
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